Table 2:
FGFR2 fusions or rearrangements (n=107) | Other FGF/FGFR alterations (n=20) | No FGF/FGFR alterations (n=18) | |
---|---|---|---|
Proportion of patients with an objective response | 35·5% (26·5 to 45·4) | 0 | 0 |
Best overall response* | |||
Complete response | 3 (2·8%) | 0 | 0 |
Partial response | 35 (32·7%) | 0 | 0 |
Stable disease | 50 (46·7%) | 8 (40·0%) | 4 (22·2%) |
Progressive disease | 16 (14·9%) | 7 (35·0%) | 11 (61·1%) |
Not evaluable | 3 (2·8%) | 5 (25·0%) | 3 (16·7%) |
Duration of response | |||
Patients with events | 21/38 (55%) | 0 | 0 |
Patients censored | 17/38 (45%) | 0 | 0 |
Median duration of response, months | 7·5 (5·7 to 14·5) | .. | .. |
Kaplan-Meier estimated probability of retaining a response | |||
At 6 months | 68% (49 to 82) | .. | .. |
At 12 months | 37% (19 to 56) | .. | .. |
Proportion of patients with disease control | 82% (74 to 89) | 40% (19 to 64) | 22% (6 to 48) |
Progression-free survival | |||
Patients with events | 71 (66%) | 17 (85%) | 16 (89%) |
Patients censored | 36 (34%) | 3 (15%) | 2 (11%) |
Median, months | 6·9 (6·2 to 9·6) | 2·1 (1·2 to 4·9) | 1·7 (1·3 to 1·8) |
Kaplan-Meier estimates of progression-free survival | |||
At 6 months | 62% (52 to 70) | 25% (8 to 47) | 6% (<1 to 25) |
At 12 months | 29% (19 to 40) | 0 | 0 |
Overall survival† | |||
Patients with events | 40 (37%) | 16 (80%) | 14 (78%) |
Patients censored | 67 (63%) | 4 (20%) | 4 (22%) |
Median overall survival, months | 21·1 (14·8 to not estimable) | 6·7 (2·1 to 10·6) | 4·0 (2·3 to 6·5) |
Kaplan-Meier estimates of overall survival | |||
At 6 months | 89% (81 to 93) | 51% (26 to 71) | 31% (11 to 54) |
At 12 months | 68% (56 to 76) | 23% (7 to 43) | 13% (2 to 33) |
Data are % (95% CI), n (%), or months (95% CI). FGFR=fibroblast growth factor receptor.
Assessed and response confirmed by independent reviewer (95% CIs not available for individual response values).
Overall survival data were not mature at data cutoff.